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Maintenance of Shoulder Health and Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoulder home exercise program
Sponsored by
Rancho Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Shoulder Pain, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • spinal cord injury
  • at least 2 years duration post spinal cord injury and no greater than 20 years duration post spinal cord injury
  • at least 18 years of age
  • free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study
  • a total score on the "Wheelchair User's Shoulder Pain Index" of 10 or less
  • adequate arm strength and movement to perform the shoulder exercise program

Exclusion Criteria:

  • positive shoulder impingement signs (positive Hawkins-Kennedy test and painful arc in shoulder abduction or flexion)
  • biceps tendonitis (positive Speed's test)
  • adhesive capsulitis, or cervical radiculopathy
  • a history of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function

Sites / Locations

  • Rancho Los Amigos National Rehabilitaiton Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

One-to-one training group for shoulder home exercise program

Enhanced training group for shoulder home exercise program

Historical control group

Arm Description

Patients will attend two sessions of one-to-one training with a physical therapist to learn the shoulder home exercise program. The sessions are 4 weeks apart. They will also review a handout on techniques to protect their shoulder during wheelchair propulsion and transfers.

Patients will attend four classes held each week for 4 consecutive weeks. The classes are led by a physical therapist and a peer mentor (with a spinal cord injury). Two to four research patients are in each class. Classes begin with an interactive education presentation on techniques and recommendations to protect the shoulder during transfers, wheelchair propulsion, raises and activities of daily living. This is followed by performance of the home exercise program. Patients will be called every 3 to 6 months by a peer mentor to receive encouragement, praise, and/or problem solve barriers to exercise.

Historical control group has received no intervention. Eligibility criteria, outcome measures and study duration for historical control group is matched for the experimental group and active comparator.

Outcomes

Primary Outcome Measures

Presence of shoulder pain
Presence of shoulder pain will be measured using the "Wheelchair User's Shoulder Pain Index". This questionnaire uses a visual analog scale to rate level of shoulder pain during the previous week while performing 15 common daily activities such as transferring from the bed to a wheelchair or pushing a wheelchair > 10 minutes.

Secondary Outcome Measures

Activity levels
Patients will be called every 2-3 months to report the frequency and intensity of their shoulder exercise program. Patients will be asked questions about their arm use specific to their functional abilities during the previous 1 to 3 days, such as the number of transfers performed, number of depression raises performed, how often they use their arms for chores or use their arms to help with walking (if applicable). All patients with a manual wheelchair will have an odometer installed on their wheelchair and will report their distance and speed of wheelchair propulsion.

Full Information

First Posted
May 6, 2014
Last Updated
April 9, 2018
Sponsor
Rancho Research Institute, Inc.
Collaborators
Rancho Los Amigos National Rehabilitation Center
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1. Study Identification

Unique Protocol Identification Number
NCT02135978
Brief Title
Maintenance of Shoulder Health and Function After Spinal Cord Injury
Official Title
Southern California Spinal Cord Injury Model System: A Randomized Clinical Trial to Evaluate Two Prevention Programs for Maintenance of Shoulder Health and Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rancho Research Institute, Inc.
Collaborators
Rancho Los Amigos National Rehabilitation Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if a shoulder exercise program can prevent the onset of shoulder pain and improve community participation in persons who have a spinal cord injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be followed for 3 years to determine rate of shoulder pain development. Patients will learn a simple shoulder home exercise program and will be instructed on techniques to protect their shoulder during wheelchair propulsion, transfers and activities of daily living. Patients will be instructed to perform the home exercise program 3 days per week. Two types of treatment (training) delivery approaches that have been documented to reduce chronic shoulder pain will be compared. The rate of shoulder pain development for the two groups will be compared to the rate of shoulder pain development in the historical control group. The investigators hypothesize that the rate of shoulder pain development will be lower in the experimental treatment groups compared to the historical control group. Any differences between the two treatment delivery approaches for the experimental treatment groups will help to provide guidelines for the most effective delivery approach of a shoulder pain prevention program.
Detailed Description
All persons are at risk for shoulder pain from a shoulder injury or rotator cuff injury. Persons with SCI are at a greater risk because of the increased use of their shoulders. Lifestyle changes following SCI place a large demand on an individual's shoulders. Pushing a wheelchair, transferring, and performing pressure relief raises are three common activities that put added strain on the shoulders. In addition to these activities, reaching from a wheelchair can put strain on the shoulder because many environments are not ideally set up for wheelchair users. These new stressors are believed by the medical community to lead to shoulder pain. The prevalence of shoulder pain for persons with spinal cord injury is 30-70%. Untreated, shoulder pain may lead to additional losses in function and community mobility. Previous research shows that shoulder exercises along with education on how to improve one's technique for wheelchair propulsion, transfers, and weight relief raises can significantly reduce chronic shoulder pain and improve quality of life. The investigators aim to not only reduce existing shoulder pain, but also to prevent the onset of new pain. The current study will teach the same 4 simple shoulder strengthening exercises performed in the prior study to patients with healthy shoulders. Half of the patients will receive 2 sessions of one-to-one training with a physical therapist, and the other half will receive 4 sessions of training combined with an interactive education program on techniques to protect their shoulder in a class format led by a physical therapist and a peer mentor with a spinal cord injury. Patients will be followed for 3 years to learn if they develop shoulder pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Shoulder Pain
Keywords
Spinal Cord Injury, Shoulder Pain, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-to-one training group for shoulder home exercise program
Arm Type
Experimental
Arm Description
Patients will attend two sessions of one-to-one training with a physical therapist to learn the shoulder home exercise program. The sessions are 4 weeks apart. They will also review a handout on techniques to protect their shoulder during wheelchair propulsion and transfers.
Arm Title
Enhanced training group for shoulder home exercise program
Arm Type
Active Comparator
Arm Description
Patients will attend four classes held each week for 4 consecutive weeks. The classes are led by a physical therapist and a peer mentor (with a spinal cord injury). Two to four research patients are in each class. Classes begin with an interactive education presentation on techniques and recommendations to protect the shoulder during transfers, wheelchair propulsion, raises and activities of daily living. This is followed by performance of the home exercise program. Patients will be called every 3 to 6 months by a peer mentor to receive encouragement, praise, and/or problem solve barriers to exercise.
Arm Title
Historical control group
Arm Type
No Intervention
Arm Description
Historical control group has received no intervention. Eligibility criteria, outcome measures and study duration for historical control group is matched for the experimental group and active comparator.
Intervention Type
Other
Intervention Name(s)
Shoulder home exercise program
Intervention Description
Patients receive instruction and practice on the shoulder home exercise program, receive a notebook with handouts including pictures and written instructions on how to perform the program, and receive a kit containing the exercise equipment. Patients are asked to perform the exercises at home 3 days a week over the next 3 years.
Primary Outcome Measure Information:
Title
Presence of shoulder pain
Description
Presence of shoulder pain will be measured using the "Wheelchair User's Shoulder Pain Index". This questionnaire uses a visual analog scale to rate level of shoulder pain during the previous week while performing 15 common daily activities such as transferring from the bed to a wheelchair or pushing a wheelchair > 10 minutes.
Time Frame
36 month (3 year) evaluation time point
Secondary Outcome Measure Information:
Title
Activity levels
Description
Patients will be called every 2-3 months to report the frequency and intensity of their shoulder exercise program. Patients will be asked questions about their arm use specific to their functional abilities during the previous 1 to 3 days, such as the number of transfers performed, number of depression raises performed, how often they use their arms for chores or use their arms to help with walking (if applicable). All patients with a manual wheelchair will have an odometer installed on their wheelchair and will report their distance and speed of wheelchair propulsion.
Time Frame
Baseline and every 2-3 months over the 3 year study
Other Pre-specified Outcome Measures:
Title
Shoulder torque
Description
Shoulder torque testing will be performed using either a Biodex machine or a handheld dynamometer for the motions of isometric shoulder abduction, adduction, flexion, extension, internal rotation and external rotation.
Time Frame
Baseline, 18 month, and 36 month evaluation time points
Title
Self-Efficacy
Description
Patients will complete a questionnaire rating their confidence or self-efficacy in regards to exercise.
Time Frame
Baseline, 18 month and 36 month evaluation time points
Title
Community Participation
Description
Patients will asked to complete the questionnaire, "Reintegration To Normal Living Index".
Time Frame
Baseline, 18 month and 36 month evaluation time points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: spinal cord injury at least 2 years duration post spinal cord injury and no greater than 20 years duration post spinal cord injury at least 18 years of age free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study a total score on the "Wheelchair User's Shoulder Pain Index" of 10 or less adequate arm strength and movement to perform the shoulder exercise program Exclusion Criteria: positive shoulder impingement signs (positive Hawkins-Kennedy test and painful arc in shoulder abduction or flexion) biceps tendonitis (positive Speed's test) adhesive capsulitis, or cervical radiculopathy a history of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara J Mulroy, PhD, PT
Organizational Affiliation
Rancho Research Institute and Rancho Los Amigos National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitaiton Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21292803
Citation
Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.
Results Reference
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Maintenance of Shoulder Health and Function After Spinal Cord Injury

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